Usefulness of applying lidocaine in esophagogastroduodenoscopy performed under sedation with propofol

Table 1 Comparison of basal characteristics of patients randomly assigned to the lidocaine and placebo treatment groups

	Lidocaine	Placebo	Diff1	P2
n	59	60
Age, yr	49.7 ± 15.81	51.7 ± 14.9	-2.0 (-7.6, 3.5)	0.47
Male sex	51.10%	48.60%	1.10%	0.85
	(37.0-65.0)	(37.6-51.8)	(0.5-2.3)
Weight, kg	70.8 ± 14.0	76.6 ± 17.0	-5.8 (-0.1, -11.4)	0.04
Height, cm	162.1 ± 9.0	162.2 ± 11.0	0.10 (-3.6, 3.7)	0.50
ASA  I-II	50.4 (40.5-60.5)	46.1 (28.7-64.5)	1.10 (0.7-1.7)	0.60
Mallampati I-II	51 (41.2-60.7)	48.9 (24.4-66.5)	0.84 (0.5-1.4)	0.49
Drug abuse	50 (26.3-76.3)	49.5 (40.3-58.7)	1.00 (0.5-1.9)	1.00
Previous sedated EGD	47.6 (28.3-67.6)	50 (40.2-59.7)	0.95 (0.6-1.5)	0.80

¹Differences are expressed as RR with their respective CIs or absolute values; ²Values in bold are statistically significant. Quantitative and qualitative variables are expressed as average ± SD and as percentage with 95%CI, respectively. EGD: Esophagogastroduodenoscop.

Table 2 Influence of lidocaine on propofol dose

	Lidocaine	Placebo	Diff1	P
Average BIS	68.1 ± 7.5	68.8 ± 7.6	0.76 (-2.0, 3.5)	0.58
Total examination values
Total examination time, s	405.0 ± 134.8	387.0 ± 127.6	18.6 (-29.0, 66.2)	0.44
Total propofol dose, mg	134.9 ± 42.5	129.2 ± 40.4	5.6 (-9.4, 20.7)	0.45
Total propofol dose adjusted weight and time, mg/kg per minute	310.7 ± 139.2	280.1 ± 87.7	30.6 (-11.5, 72.7)	0.15
Intraprocedural examination values2
Partial examination time, s	281.8 ± 137.3	265.5 ± 122.3	16.3 (-30.8, 63.5)	0.49
Partial propofol dose, mg	40.9 ± 33.7	38.9 ± 31.4	2 (-9.7, 13.8)	0.73
Partial propofol dose adjusted weight and time, mg/kg per minute	135.3 ± 151.7	122.7 ± 96.5	12.6 (-33.5, 58.7)	0.58

¹Differences are expressed as RR with their respective absolute values;

²Measurements recorded from the time of endoscope insertion into the oral cavity up to the time of withdrawal, excluding the time of anaesthetic induction. Quantitative and qualitative variables are expressed as average ± standard deviation and as percentage with 95%CI, respectively. BIS: Bispectral index.

Table 3 Influence of potentially confounding factors on the propofol dose (mg/kg per minute, adjusted for patient weight and examination time)

			Diff1	P2
Age, yr
	< 65	> 65
Total propofol dose	315.3 ± 118.9	223.9 ± 73.7	91.4 (49.3, 133.5)	< 0.001
Partial3 propofol dose	138.2 ± 135.5	96.0 ± 81.4	42.2 (-5.6, 90.0)	0.08
Sex
	Male	Female
Total propofol dose	263.7 ± 87.9	314.6 ± 127.9	-59.9 (-93.8, -8.0)	0.02
Partial propofol dose	111.5 ± 101.9	139.6 ± 139	-28.1 (-75.4, 19.2)	0.20
ASA classification
	I-II	III-IV
Total propofol dose	310.8 ± 121.3	239.8 ± 77.7	71.0 (21.2, 120.8)	< 0.001
Partial propofol dose	135.9 ± 136.3	104.1 ± 80.1	31.9 (-23.6, 87.4)	0.20
Mallampati classification
	I-II	III-IV
Total propofol dose	302.4 ± 119.5	262.4 ± 98.6	40.0 (-15.3, 95.3)	0.10
Partial propofol dose	127.1 ± 133.9	137.7 ± 85.9	-10.6 (-71.5, 49.9)	0.70
Drug abuse
	Yes	No
Total propofol dose	320.5 ± 92.1	293.0 ± 118.7	27.5 (-48.9, 103.9)	0.40
Partial propofol dose	120.3 ± 87.1	129.8 ± 129	-9.5 (-92.6, 73.6)	0.80
Previous sedated EGD
	Yes	No
Total propofol dose	260.2 ± 102.7	302.8 ± 118.6	-42.6 (-97.4, 12.2)	0.10
Partial propofol dose	128.9 ± 108.4	129.0 ± 130.6	-0.1 (-60.1, 59.9)	0.90

Quantitative and qualitative variables are expressed as average ± SD and as percentage with 95%CI, respectively.

¹Differences are expressed as RR with their respective absolute values; ²Values in bold are statistically significant;

³Measurements recorded from the time of endoscope insertion into the oral cavity up to the time of withdrawal, excluding the time of anaesthetic induction. ASA: American Society of Anaesthesiologists; EGD: Esophagogastroduodenoscopy.

Table 4 Influence of lidocaine treatment on propofol dose (mg/kg per minute, adjusted for patient weight and examination time) in relation to patients’ individual characteristics

		Lidocaine	Placebo	Diff1	P2
Age, yr
< 65
	Total propofol dose	338.1 ± 138.7	292.0 ± 90.3	46.1 (-2.2, 94.4)	0.06
	Partial3 propofol dose	147.2 ± 165.6	128.9 ± 96.5	18.3 (-37.7, 74.3)	0.51
> 65
	Total propofol dose	203.6 ± 77.8	241.1 ± 68.0	-37.5 (-96.5, 21.5)	0.20
	Partial propofol dose	88.7 ± 61.6	102.3 ± 97.1	-13.6 (-80.8, 53.6)	0.67
Sex
Male
	Total propofol dose	280.0 ± 101.3	246.7 ± 69.6	33.3 (-19.2, 85.8)	0.20
	Partial propofol dose	97.3 ± 95.5	125.0 ± 108.0	-27.7 (-33.7, 89.1)	0.36
Female
	Total propofol dose	330.4 ± 157.0	299.6 ± 92.1	30.8 (-28.5, 90.0)	0.30
	Partial propofol dose	141.9 ± 175.2	137.5 ± 95.2	4.4 (-60.5, 69.3)	0.89
ASA classification
I-II
	Total propofol dose	336.5 ± 141.2	284.6 ± 91.2	51.9 (2.8, 100.9)	0.03
	Partial propofol dose	149.6 ± 164.5	122.1 ± 99.6	27.5 (-28.6, 83.6)	0.16
III-IV
	Total propofol dose	209.7 ± 70.0	265.7 ± 76.7	56.0 (-3.8, 115.8)	0.06
	Partial propofol dose	79.4 ± 63.3	125.0 ± 88.9	-45.6 (-19.3, 110.5)	0.16
Mallampati classification
I-II
	Total propofol dose	319.6 ± 140.0	284.3 ± 91.4	35.4 (-12.2, 83.0)	0.14
	Partial propofol dose	136.1 ± 159.2	117.7 ± 102.1	18.4 (-35.4, 72.2)	0.49
III-IV
	Total propofol dose	260.8 ± 130.7	263.6 ± 72.3	-2.8 (-96.0, 90.5)	0.95
	Partial propofol dose	130.8 ± 108.0	142.8 ± 69.9	-12.0 (-93.2, 69.2)	0.76
Drug abuse
Yes
	Total propofol dose	313.5 ± 115.2	327.6 ± 75.4	-14.1 (-156.1, 127.9)	0.82
	Partial propofol dose	96.1 ± 100.8	144.4 ± 73.8	-48.3 (-177.1, 80.5)	0.41
No
	Total propofol dose	310.5 ± 142.2	275.9 ± 88.2	34.6 (-10.2, 79.4)	0.12
	Partial propofol dose	138.9 ± 155.1	120.8 ± 98.6	18.1 (-31.1, 67.3)	0.46
Previous sedated EGD
Yes
	Total propofol dose	297.6 ± 116.3	226.1 ± 79.1	71.6 (-18.4, 161.7)	0.11
	Partial propofol dose	124.4 ± 129.5	132.9 ± 91.5	-8.5 (-110.1, 93.1)	0.86
No
	Total propofol dose	313.4 ± 144.4	292.3 ± 85.7	21.1 (-26.9, 69.1)	0.38
	Partial propofol dose	137.5 ± 157.0	120.4 ± 98.4	17.1 (-35.8, 70.0)	0.52

Quantitative and qualitative variables are expressed as average ± SD and as percentage with 95%CI, respectively.

¹Differences are expressed as RR with their respective absolute values; ²Values in bold are statistically significant;

³Measurements recorded from the time of endoscope insertion into the oral cavity up to the time of withdrawal, excluding the time of anaesthetic induction. ASA: American Society of Anaesthesiologists; EGD: Esophagogastroduodenoscopy.

Table 5 Distribution of complications between groups

	Lidocaine	Placebo	Diff1	P
Complications	32.2 (21.6-45.0)	26.7 (17.0-39.0)	1.2 (0.7-2.1)	0.50
Desaturation	57.1 (25.0-84.2)	54.5 (38.0-70.1)	1.0 (0.5-2.1)	0.90
Hypotension	63.6 (42.9-80.3)	66.6 (43.6-84.0)	0.95 (0.6-1.5)	0.80
Bradycardia	13.6 (3.9-34.2)	25.0 (6.3-55.9)	0.5 (0.1-2.7)	0.46
Aspiration	0 (0-17.4)	5.5 (0-27.6)	-	0.26
Bronchospasm	9.0 (1.3-29.0)	0 (0-20.7)	-	0.19

¹Differences are expressed as RR with their respective CIs. Variables are expressed as percentage with 95%CI. The complication subcategories report incidence in relation to total complications.

Table 6 Distribution of complications according to individual risk factors of patients in endoscopy sedation

			Diff1	P
Age, yr
	< 65	> 65
	22.8 (11.8-39.2)	17.6 (10.8-27.2)	1.3 (0.6-2.7)	0.25
Sex
	Male	Female
	31.4 (18.4-48.1)	41.2 (31.3-51.8)	0.7 (0.4-1.3)	0.15
ASA classification
	I-II	III-IV
	22.8 (11.8-39.2)	21.2 (13.7-31.1)	1.1 (0.5-2.2)	0.41
Mallampati classification
	I-II	III-IV
	17.1 (7.7-33.0)	17.6 (10.9-27.2)	0.9 (0.4-2.3)	0.47
Drug abuse
	Yes	No
	2.8 (0-15.8)	10.6 (5.4-19.1)	0.2 (0.01-2.0)	0.08
Propofol dose2
	> 277	< 277
	30.5 (20.2-43.2)	26.7 (17.0-39.1)	1.1 (0.6-2.0)	0.32
Average BIS
	< 70	> 70
	33.3 (24.0-44.2)	21.0 (10.8-36.6)	1.6 (0.8-3.1)	0.08
Previous sedated EGD
	Yes	No
	17.1 (7.7-33.0)	20.0 (12.4-30.5)	0.8 (0.3-2.0)	0.36

¹Differences are expressed as RR with their respective CIs;

²The propofol dose is reported as the cut-off point calculated as the mean of the total propofol dose administered to the patients in the trial: 277 mg/kg per minute. Variables are expressed as percentage with 95%CI. BIS: Bispectral index; ASA: American Society of Anaesthesiologists; EGD: Esophagogastroduodenoscopy.